Humira, Trudexa(adalimumab)
Abrilada, Amgevita, Amjevita, Amsparity, Cyltezo, Hadlima, Hefiya, Hukyndra, Hulio, Humira, Hyrimoz, Idacio, Imraldi, Libmyris, Simlandi, Yuflyma, Yusimry (adalimumab) is an antibody pharmaceutical. Adalimumab was first approved as Humira on 2002-12-31. It is used to treat ankylosing spondylitis, crohn disease, hidradenitis suppurativa, juvenile arthritis, and psoriatic arthritis amongst others in the USA. It has been approved in Europe to treat ankylosing spondylitis, arthritis, crohn disease, hidradenitis suppurativa, and papulosquamous skin diseases amongst others. The pharmaceutical is active against tumor necrosis factor.
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Commercial
Trade Name
FDA
EMA
Amjevita, Cyltezo, Hadlima, Hulio, Humira, Hyrimoz, Idacio, Yusimry (discontinued: Abrilada)
Drug Products
FDA
EMA
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| abrilada | Biologic Licensing Application | 2024-01-26 |
| adalimumab | Biologic Licensing Application | 2023-12-08 |
| adalimumab-aacf | Biologic Licensing Application | 2023-12-02 |
| adalimumab-adbm | Biologic Licensing Application | 2023-09-20 |
| amjevita | Biologic Licensing Application | 2024-02-05 |
| cyltezo | Biologic Licensing Application | 2023-07-12 |
| hadlima | Biologic Licensing Application | 2023-10-23 |
| hulio | Biologic Licensing Application | 2023-12-30 |
| humira | Biologic Licensing Application | 2024-02-01 |
| hyrimoz | Biologic Licensing Application | 2023-06-15 |
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Indications
FDA
EMA
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
adalimumab, Cyltezo, Boehringer Ingelheim Pharmaceuticals, Inc. | |||
| Date TBD | Interchangeable excl. | ||
adalimumab, Humira, AbbVie Inc. | |||
| 2028-02-24 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J0135 | Injection, adalimumab, 20 mg |
Clinical
Clinical Trials
738 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | 4 | 26 | 57 | 64 | 91 | 239 |
| Psoriasis | D011565 | EFO_0000676 | L40 | 3 | 10 | 34 | 21 | 47 | 111 |
| Crohn disease | D003424 | EFO_0000384 | K50 | 3 | 8 | 31 | 22 | 51 | 110 |
| Ulcerative colitis | D003093 | EFO_0000729 | K51 | 3 | 4 | 13 | 9 | 39 | 67 |
| Ankylosing spondylitis | D013167 | EFO_0003898 | M45 | 1 | 3 | 9 | 9 | 35 | 56 |
| Psoriatic arthritis | D015535 | EFO_0003778 | L40.5 | 1 | 2 | 11 | 7 | 33 | 54 |
| Inflammatory bowel diseases | D015212 | EFO_0003767 | — | 2 | 3 | 2 | 7 | 21 | 33 |
| Uveitis | D014605 | HP_0000554 | H20.9 | 1 | 7 | 8 | 3 | 4 | 21 |
| Hidradenitis suppurativa | D017497 | — | L73.2 | 1 | 7 | 4 | 3 | 6 | 21 |
| Spondylarthritis | D025241 | — | — | — | — | 1 | 6 | 5 | 12 |
Show 17 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 24 | 1 | 1 | — | — | 25 |
| Juvenile arthritis | D001171 | EFO_1002007 | M08 | — | 1 | 6 | — | 4 | 10 |
| Pain | D010146 | EFO_0003843 | R52 | 1 | 1 | 1 | — | 2 | 4 |
| Inflammation | D007249 | MP_0001845 | — | — | 1 | 1 | — | 2 | 4 |
| Behcet syndrome | D001528 | EFO_0003780 | M35.2 | — | — | 2 | — | 2 | 4 |
| Pyoderma gangrenosum | D017511 | EFO_0006835 | L88 | — | 2 | 1 | — | 1 | 4 |
| Autoimmune diseases | D001327 | HP_0002960 | M30-M36 | 1 | 2 | 1 | — | — | 3 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | 1 | 2 | 1 | — | — | 3 |
| Covid-19 | D000086382 | — | U07.1 | — | — | 1 | — | — | 1 |
| Pouchitis | D019449 | EFO_0003921 | K91.850 | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sarcoidosis | D012507 | EFO_0000690 | D80-D89 | — | 4 | — | — | — | 4 |
| Focal segmental glomerulosclerosis | D005923 | EFO_0004236 | — | 1 | 2 | — | — | — | 3 |
| Choroidal neovascularization | D020256 | — | — | 1 | 1 | — | — | — | 2 |
| Mucopolysaccharidosis vi | D009087 | — | — | 2 | 2 | — | — | — | 2 |
| Mucopolysaccharidosis i | D008059 | — | E76.0 | 2 | 2 | — | — | — | 2 |
| Mucopolysaccharidosis ii | D016532 | — | E76.1 | 2 | 2 | — | — | — | 2 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | 1 | 1 | — | — | — | 1 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 1 | 1 | — | — | — | 1 |
| Hypoglycemia | D007003 | HP_0001943 | E16.2 | 1 | 1 | — | — | — | 1 |
| Hermanski-pudlak syndrome | D022861 | — | E70.331 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Uveal neoplasms | D014604 | EFO_1001230 | — | 1 | — | — | — | — | 1 |
| Immune system diseases | D007154 | — | D89.9 | 1 | — | — | — | — | 1 |
| Therapeutic equivalency | D013810 | — | — | 1 | — | — | — | — | 1 |
| Anaplastic thyroid carcinoma | D065646 | — | — | 1 | — | — | — | — | 1 |
| Innate immunity | D007113 | — | — | 1 | — | — | — | — | 1 |
| Diabetic retinopathy | D003930 | EFO_0003770 | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Fatigue | D005221 | HP_0012378 | R53.83 | — | — | — | — | 2 | 2 |
| Rheumatic diseases | D012216 | — | M79.0 | — | — | — | — | 2 | 2 |
| Depression | D003863 | — | F33.9 | — | — | — | — | 2 | 2 |
| Anxiety | D001007 | EFO_0005230 | F41.1 | — | — | — | — | 2 | 2 |
| Drug monitoring | D016903 | — | — | — | — | — | — | 2 | 2 |
| Brain diseases | D001927 | HP_0001298 | G93.40 | — | — | — | — | 1 | 1 |
| Cognitive dysfunction | D060825 | HP_0001268 | G31.84 | — | — | — | — | 1 | 1 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | — | — | — | 1 | 1 |
| Dementia | D003704 | EFO_0003862 | F03 | — | — | — | — | 1 | 1 |
| Infections | D007239 | EFO_0000544 | — | — | — | — | — | 1 | 1 |
Show 13 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Adalimumab |
| INN | adalimumab |
| Description | Adalimumab, sold under the brand name Humira among others, is a medication used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, psoriasis, hidradenitis suppurativa, uveitis, and juvenile idiopathic arthritis. Use is generally only recommended in people who have not responded to other treatments. It is used by injection under the skin.
|
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | >6CR1:H|Heavy chain of adalimumab EFab (VH-IgE CH2)
EVQLVESGGGLVQPGRSLRLSCAASGFTFDDYAMHWVRQAPGKGLEWVSAITWNSGHIDYADSVEGRFTISRDNAKNSLY
LQMNSLRAEDTAVYYCAKVSYLSTASSLDYWGQGTLVTVSSASTKGPTVKILQSICDGGGHFPPTIQLLCLVSGYTPGTI
QITWLEDGQVMDVDLSTASTTQEGELASTQSELTLSQKHWLSDRTYTCQVTYQGHTFEDSTKKCAHHHHHH
>6CR1:L|Light chain of adalimumab EFab (VL-IgE CH2)
DIQMTQSPSSLSASVGDRVTITCRASQGIRNYLAWYQQKPGKAPKLLIYAASTLQSGVPSRFSGSGSGTDFTLTISSLQP
EDVATYYCQRYNRAPYTFGQGTKVEIKRTVAAPTVKILQSSCDGGGHFPPTIQLLCLVSGYTPGTIQITWLEDGQVMDVD
LSTASTTQEGELASTQSELTLSQKHWLSDRTYTCQVTYQGHTFEDSGKKCA |
Identifiers
| PDB | 3WD5, 4NYL, 6CR1 |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201580 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB00051 |
| UNII ID | FYS6T7F842 (ChemIDplus, GSRS) |
Target
Agency Approved
TNF
TNF
Organism
Homo sapiens
Gene name
TNF
Gene synonyms
TNFA, TNFSF2
NCBI Gene ID
Protein name
tumor necrosis factor
Protein synonyms
APC1 protein, Cachectin, TNF, macrophage-derived, TNF, monocyte-derived, TNF-a, TNF-alpha, tumor necrosis factor ligand 1F, Tumor necrosis factor ligand superfamily member 2, tumor necrosis factor-alpha, tumor necrotic factor alpha
Uniprot ID
Mouse ortholog
Tnf (21926)
tumor necrosis factor (P06804)
Alternate
No data
Variants
No data
Financial
Revenue by drug
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€
£
₣
Hadlima – Organon
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Yusimry – Coherus BioSciences
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Humira – AbbVie
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Humira – Alvotech
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Imraldi – Biogen
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Tabular view
Estimated US medical usage
Adalimumab
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 29,865 documents
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Safety
Black-box Warning
Black-box warning for: Abrilada, Adalimumab, Adalimumab-aacf, Adalimumab-adbm, Amjevita, Cyltezo, Hadlima, Hulio, Humira, Hyrimoz, Idacio, Yuflyma, Yusimry
Adverse Events
Top Adverse Reactions
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552,535 adverse events reported
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